510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GSNClass II

Antiserum, Positive And Negative Febrile Antigen Control Serum

21 CFR 866.3085 / Microbiology
FDA source (opens on fda.gov)

GSN is the FDA product code for Antiserum, Positive And Negative Febrile Antigen Control Serum, a class II device type, regulated under 21 CFR 866.3085. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GSN
Device name
Antiserum, Positive And Negative Febrile Antigen Control Serum
Regulation
21 CFR 866.3085
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
2

Clearances, product code GSN

By decision year
3 clearances under product code GSN with a decision year between 1979 and 1995, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GSN by decision year
YearClearances
19791
19891
19951

Applicants with the most clearances

Product code GSN
Applicants holding the most 510(k) clearances under product code GSN
ApplicantClearances
IMMY, Inc.1
Investigacion Farmaceutica S.A. de C.V.1
SA Scientific, Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code